Recall Z-0452-2021 ยท LZH Pump, Infusion, Enteral
Cardinal Health 200, LLC
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
| Date | Sep 22, 2020 |
| Status | Open, Classified |
| Reason | The feeding spike sets may leak at the interface of the tube and spike connector. |
| Root cause | Process control |
| Action | A Product Correction Notice dated 922/20 was sent to customers. Cardinal Health had previously notified customers of a Medical Device Product Advisory in December 2019 due to the potential risk of leaks with Kangaroo enteral feeding spike sets*. The purpose of this communication is to inform you that we have updated this notification to include all unexpired lots manufactured to date, in addition, we have added two additional product codes of Kangaroo Connect 500ml and 1000ml bag sets to the product correction notice. The Product Correction Notice is for all unexpired lots of the below Kangar |
| Quantity | 314460 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal Covidien, Jul 6, 2016 |